In February, the US Food and Drug Administration (FDA) approved drugs relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for geographic atrophy secondary to age-related macular degeneration, proteinuria in adults with primary immunoglobulin A nephropathy, tardive dyskinesia and chorea associated with Huntington disease, and anemia due to chronic kidney disease.
SyfovreTM for Geographic Atrophy Secondary to AMD
The FDA has approved SyfovreTM (pegcetacoplan injection, for intravitreal use) to treat geographic atrophy, a leading cause of blindness, that occurs secondary to age-related macular degeneration (AMD). This is the first drug approved for this indication.
Approval was based on data from the phase 3 DERBY (ClinicalTrials.gov Identifier: NCT03525600) and OAKS (ClinicalTrials.gov Identifier: NCT03525613) studies that evaluated the safety and efficacy of intravitreal pegcetacoplan in 1258 patients for 24 months.
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In DERBY, treatment with pegcetacoplan monthly and every other month injections reduced the rate of GA lesion growth by 18.1% and 17.4%, respectively, from baseline to month 24. In OAKS, treatment with the same regimen reduced the rate of GA lesion growth by 21.9% and 18.1%, respectively, from baseline to month 24.
The most common adverse reactions reported were ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage.
Syfovre is supplied in a single-dose vial containing 150 mg/mL of pegcetacoplan and is expected to be available in early March.
Filspari™ for Proteinuria in IgA Nephropathy
The FDA granted accelerated approval to Filspari™ (sparsentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g.
Approval was based on data from the phase 3 PROTECT study (ClinicalTrials.gov Identifier: NCT03762850), which showed that patients treated with sparsentan (n=141) achieved a mean reduction in proteinuria of 45% (95% CI, -51 to -38) vs 15.1% (95% CI, -24 to -4) with irbesartan (n=140) after 36 weeks of treatment (sparsentan vs irbesartan: ratio of adjusted geometric mean relative to baseline at week 36, 0.65 [95% CI, 0.55-0.77]; P <.0001).
The most common adverse reactions reported include peripheral edema, hypotension, dizziness, hyperkalemia, and anemia. Labeling for the agent includes a Boxed Warning regarding the risk of hepatotoxicity and embryo-fetal toxicity. The medication is only available through a restricted distribution program called the Filspari Risk Evaluation and Mitigation Strategy (REMS).
Filspari is supplied as 200 mg and 400 mg tablets and is expected to be available the last week of February.
Austedo® XR for Tardive Dyskinesia and Chorea Associated with Huntington Disease
Austedo® XR, a once-daily formulation of deutetrabenazine, was approved by the FDA for the treatment of tardive dyskinesia and chorea associated with Huntington disease in adults.
The once-daily formulation has shown to be therapeutically equivalent to the twice-daily formulation, therefore, the same total daily dosage can be used when switching between Austedo (twice daily) tablets and Austedo XR (once daily) tablets. The new once-daily formulation can be administered with or without food.
Austedo XR is supplied as 6 mg, 12 mg, and 24 mg strength extended-release tablets. The product is expected to be available later this year.
Jesduvroq for Anemia of Chronic Kidney Disease
Jesduvroq (daprodustat) was approved by the FDA for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months.
Approval was based on data from the phase 3 ASCEND-D trial that included 2964 patients with anemia of CKD who were on dialysis. Patients were randomly assigned to receive daprodustat or a recombinant human erythropoietin (rhEPO).
Patients in the daprodustat arm achieved a mean change in hemoglobin level of 0.3±0.02 g/dL compared with 0.10±0.02 g/dL in the rhEPO arm (difference, 0.2 g/dL; 95% CI, 0.1-0.2), which met the prespecified noninferiority margin of -0.7 5g/dL. After a median follow-up of 2.5 years, MACE occurred in 25.2% (n=374/1487) of patients in the daprodustat arm and 26.7% (n=394/1477) of patients in the rhEPO arm (hazard ratio, 0.93; 95% CI, 0.81-1.07), which met the prespecified noninferiority margin.
The most common adverse reactions reported were hypertension, thrombotic vascular events, and abdominal pain. The drug’s labeling includes a Boxed Warning for an increased risk of thrombotic vascular events including death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
Jesduvroq is supplied as 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg tablets and is administered daily without regard to the timing or type of dialysis. The agent is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia or for treatment of anemia of CKD in patients who are not on dialysis.
References
1. Syfovre. Prescribing information. Apellis Pharmaceuticals, Inc.; 2023. Accessed February 23, 2023. https://pi.apellis.com/files/PI_SYFOVRE.pdf.
2. Filspari. Prescribing information. Travere Therapeutics; 2023. Accessed February 23, 2023. https://travere.com/wp-content/uploads/2023/02/filspari-final-uspi-20230217.pdf.
3. Austedo XR. Prescribing information. Teva Pharmaceuticals; 2023. Accessed February 23, 2023. https://www.austedo.com/globalassets/austedo/prescribing-information.pdf.
4. Jesduvroq. Prescribing instructions. GSK plc; 2023. Accessed February 23, 2023. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jesduvroq/pdf/JESDUVROQ-PI-MG.PDF.
